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PROlonGed ExpoSure Sertraline (PROGrESS)

Primary Purpose

Posttraumatic Stress Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sertraline

Prolonged Exposure Therapy

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring combat-related PTSD, Posttraumatic stress disorder, prolonged exposure therapy, sertraline, military, veterans, VA hospital, mental illness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) combat veteran with chronic posttraumatic stress disorder (PTSD) or significant PTSD symptoms (Clinician Administered Posttraumatic Stress Disorder Scale [CAPS] >= 50) of at least 3 months duration

Exclusion Criteria:

Current, imminent risk of suicide (as indicated on C-SSRS)
Active psychosis
Alcohol or substance dependence in the past 8 weeks
Unable to attend regular appointments
Prior intolerance or failure of adequate trial of prolonged exposure (PE) or sertraline (SERT) (defined as at least 2 months of SERT at least 100mg/day)
Medical illness likely to result in hospitalization or for which treatments are contraindicated (based on lab results, medical history and physical exam)
Serious cognitive impairment (as evidenced by cognitive impairment felt likely to interfere with the ability to participate meaningfully in the study)
Concurrent antidepressants or antipsychotics
Pregnant females

Sites / Locations

VA San Diego Healthcare System
Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic
Massachusetts General Hospital
Veterans Affairs Ann Arbor Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Sertraline + enhanced medication management (SERT/EMM)

Prolonged Exposure + sertraline (PE/SERT)

Prolonged Exposure + placebo (PE/PLB)

Arm Description

24 weeks of sertraline + enhanced medication management

Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo

Outcomes

Primary Outcome Measures

Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)

Total Score; Range 0-136 with increasing PTSD severity as scores increase

Secondary Outcome Measures

Patient Health Questionnaire-15

PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe

Full Information

NCT ID

NCT01524133

First Posted

January 27, 2012

Last Updated

January 30, 2018

Sponsor

VA Ann Arbor Healthcare System

Collaborators

U.S. Army Medical Research and Development Command

1. Study Identification

Unique Protocol Identification Number

NCT01524133

Brief Title

PROlonGed ExpoSure Sertraline

Acronym

PROGrESS

Official Title

Randomized Trial of Sertraline, Prolonged Exposure, and Their Combination for Post-traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF).

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

VA Ann Arbor Healthcare System

Collaborators

U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition, the investigators are examining predictors of response to these two treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such treatments. Biological mechanisms of change are also examined including emotion processing and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the investigators will examine acceptability of each treatment and reasons for ending treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

Keywords

combat-related PTSD, Posttraumatic stress disorder, prolonged exposure therapy, sertraline, military, veterans, VA hospital, mental illness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

223 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sertraline + enhanced medication management (SERT/EMM)

Arm Type

Active Comparator

Arm Description

24 weeks of sertraline + enhanced medication management

Arm Title

Prolonged Exposure + sertraline (PE/SERT)

Arm Type

Active Comparator

Arm Description

Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Arm Title

Prolonged Exposure + placebo (PE/PLB)

Arm Type

Active Comparator

Arm Description

Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo

Intervention Type

Drug

Intervention Name(s)

Sertraline

Other Intervention Name(s)

Zoloft

Intervention Description

Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Intervention Type

Behavioral

Intervention Name(s)

Prolonged Exposure Therapy

Intervention Description

up to 13 sessions of prolonged exposure

Primary Outcome Measure Information:

Title

Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)

Description

Total Score; Range 0-136 with increasing PTSD severity as scores increase

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Patient Health Questionnaire-15

Description

PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe

Time Frame

24 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) combat veteran with chronic posttraumatic stress disorder (PTSD) or significant PTSD symptoms (Clinician Administered Posttraumatic Stress Disorder Scale [CAPS] >= 50) of at least 3 months duration Exclusion Criteria: Current, imminent risk of suicide (as indicated on C-SSRS) Active psychosis Alcohol or substance dependence in the past 8 weeks Unable to attend regular appointments Prior intolerance or failure of adequate trial of prolonged exposure (PE) or sertraline (SERT) (defined as at least 2 months of SERT at least 100mg/day) Medical illness likely to result in hospitalization or for which treatments are contraindicated (based on lab results, medical history and physical exam) Serious cognitive impairment (as evidenced by cognitive impairment felt likely to interfere with the ability to participate meaningfully in the study) Concurrent antidepressants or antipsychotics Pregnant females

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheila Rauch, PhD

Organizational Affiliation

VA Ann Arbor Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA San Diego Healthcare System

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

Facility Name

Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Veterans Affairs Ann Arbor Healthcare System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34147766

Citation

Allard CB, Norman SB, Straus E, Kim HM, Stein MB, Simon NM, Rauch SAM; PROGrESS Study Team. Reductions in guilt cognitions following prolonged exposure and/or sertraline predict subsequent improvements in PTSD and depression. J Behav Ther Exp Psychiatry. 2021 Dec;73:101666. doi: 10.1016/j.jbtep.2021.101666. Epub 2021 Jun 1.

Results Reference

derived

PubMed Identifier

34133087

Citation

Rauch SAM, Kim HM, Lederman S, Sullivan G, Acierno R, Tuerk PW, Simon NM, Venners MR, Norman SB, Allard CB, Porter KE, Martis B, Bui E, Baker AW; PROGrESS Team. Predictors of Response to Prolonged Exposure, Sertraline, and Their Combination for the Treatment of Military PTSD. J Clin Psychiatry. 2021 Jun 15;82(4):20m13752. doi: 10.4088/JCP.20m13752.

Results Reference

derived

PubMed Identifier

32668087

Citation

Sheynin J, Duval ER, King AP, Angstadt M, Phan KL, Simon NM, Rauch SAM, Liberzon I. Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder. Depress Anxiety. 2020 Oct;37(10):1037-1046. doi: 10.1002/da.23075. Epub 2020 Jul 15.

Results Reference

derived

PubMed Identifier

32446108

Citation

Rauch SAM, King A, Kim HM, Powell C, Rajaram N, Venners M, Simon NM, Hamner M, Liberzon I. Cortisol awakening response in PTSD treatment: Predictor or mechanism of change. Psychoneuroendocrinology. 2020 Aug;118:104714. doi: 10.1016/j.psyneuen.2020.104714. Epub 2020 May 15.

Results Reference

derived

PubMed Identifier

32306485

Citation

Duval ER, Sheynin J, King AP, Phan KL, Simon NM, Martis B, Porter KE, Norman SB, Liberzon I, Rauch SAM. Neural function during emotion processing and modulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder. Depress Anxiety. 2020 Jul;37(7):670-681. doi: 10.1002/da.23022. Epub 2020 Apr 19.

Results Reference

derived

PubMed Identifier

32278278

Citation

Joshi SA, Duval ER, Sheynin J, King AP, Phan KL, Martis B, Porter KE, Liberzon I, Rauch SAM. Neural correlates of emotional reactivity and regulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder. Psychiatry Res Neuroimaging. 2020 May 30;299:111062. doi: 10.1016/j.pscychresns.2020.111062. Epub 2020 Mar 5.

Results Reference

derived

PubMed Identifier

32216142

Citation

Goetter EM, Hoeppner SS, Khan AJ, Charney ME, Wieman S, Venners MR, Avallone KM, Rauch SAM, Simon NM. Combat-Related Posttraumatic Stress Disorder and Comorbid Major Depression in U.S. Veterans: The Role of Deployment Cycle Adversity and Social Support. J Trauma Stress. 2020 Jun;33(3):276-284. doi: 10.1002/jts.22496. Epub 2020 Mar 26.

Results Reference

derived

PubMed Identifier

30516797

Citation

Rauch SAM, Kim HM, Powell C, Tuerk PW, Simon NM, Acierno R, Allard CB, Norman SB, Venners MR, Rothbaum BO, Stein MB, Porter K, Martis B, King AP, Liberzon I, Phan KL, Hoge CW. Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Feb 1;76(2):117-126. doi: 10.1001/jamapsychiatry.2018.3412.

Results Reference

derived

PubMed Identifier

29081351

Citation

Rauch SAM, Simon NM, Kim HM, Acierno R, King AP, Norman SB, Venners MR, Porter K, Phan KL, Tuerk PW, Allard C, Liberzon I, Rothbaum BO, Martis B, Stein MB, Hoge CW. Integrating biological treatment mechanisms into randomized clinical trials: Design of PROGrESS (PROlonGed ExpoSure and Sertraline Trial). Contemp Clin Trials. 2018 Jan;64:128-138. doi: 10.1016/j.cct.2017.10.013. Epub 2017 Oct 29.

Results Reference

derived

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PROlonGed ExpoSure Sertraline

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